Megestrol in Treating Patients With Endometrial Neoplasia or Endometrial Hyperplasia (NCT00503581) | Clinical Trial Compass
TerminatedPhase 2
Megestrol in Treating Patients With Endometrial Neoplasia or Endometrial Hyperplasia
United States9 participantsStarted 2007-07
Plain-language summary
This randomized phase II trial is studying how well megestrol works in treating patients with endometrial neoplasia or endometrial hyperplasia. Estrogen can cause the growth of endometrial cancer cells. Hormone therapy using megestrol may fight endometrial cancer by blocking the use of estrogen by the abnormal cells.
Who can participate
Age range18 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients must have a diagnosis of atypical endometrial hyperplasia (AEH) or endometrial intraepithelial neoplasia (EIN) diagnosed by dilatation and curettage (D\&C), Novak curettage, Vabra aspirate, or Pipelle endometrial biopsy at the enrolling institution within 12 weeks of enrollment
* Patients must desire uterine retention for duration of study (18 months or after 3rd biopsy) if they remain EIN negative (-); patients are allowed to attempt pregnancy after their initial post-treatment biopsy without it being a major protocol violation
* Patients must have a GOG performance status of 0, 1, or 2
* White blood cell (WBC) \>= 3000
* Platelets \>= 100,000
* Granulocytes \>= 1,500
* Creatinine =\< 2
* Bilirubin =\< 1.5 x institutional upper limit normal
* Serum glutamic oxaloacetic transaminase (SGOT) =\< 3 x institutional upper limit normal
* Alkaline phosphatase =\< 3 x institutional upper limit normal
* Patients of child-bearing potential must have a negative serum pregnancy test prior to starting study drug and prior to each biopsy if capable of becoming pregnant (and at the discretion of the referring physician)
* Patients of childbearing potential must use appropriate non-hormonal contraception while on study medication
* Patients who have met the pre-entry requirements
* Patients must have signed an approved informed consent and authorization permitting release of personal health information
Exclusion Criteria:
* Patients with a GOG performance st…
What they're measuring
1
Number of Patients Who Experience a Response as Determined by a Central Blinded Review of the Three Post Treatment Endometrial
Timeframe: Up to 12 months after completion of treatment